跳至主要内容
临床试验/CTRI/2024/09/073715
CTRI/2024/09/073715尚未招募Phase 3 4

Comparative Evaluation of the Efficacy of Eggshell Derived Hydroxyapatite (EHA) with Commercial Available Synthetic Hydroxyapatite (SHA) In Bone Regeneration following Periapical Cyst Enucleation.

Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月10日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
The effect of grafting will be evaluated using digital radiographic imaging technique and computer densitometry in bone regeneration at time intervals of 3,6 and 9 months following periapical cyst enucleation.

研究概览

简要总结

To promote healing of large bone defects using graft material is well known. Missing bone is

replaced traditionally with material either from patient or donor. Clinicians and scientists are

in search of alternative bone graft substitutes because of factors like donor site morbidity, time,

and skill required for second surgery to harvest graft, inadequate quantity available with respect

to auto grafts, and so. Multiple sources and different forms of bone grafts have been used for

bone augmentation and reconstruction in oral maxillofacial and orthopedic surgery to stimulate

bone healing since long time. In recent years, use of synthetic or processed bone graft substitute

has gained popularity over traditional grafting methods.

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Hydroxyapatite (HA) is apatite calcium phosphate Ca10(PO4)6(OH)2. In many disciplines of

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surgery HA is being used as graft material successfully. In particular, HA shows highest level

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of bioactivity and forms a quick bond with bone.

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The eggshell formulations are being used since beginning as trace element and mineral

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supplying agents. Few studies show surface modified eggshell powder as osteoconductive bone

Objective of the study:

  1. To assess the efficacy of eggshell derived hydroxyapatite in terms of bone regeneration by densitometer after 3,6 and 9 months following periapical cyst enucleation in maxilla and mandible
  2. To assess the efficacy of synthetic hydroxyapatite in terms of bone regeneration by densitometer after 3,6 and 9 months following periapical cyst enucleation in maxilla and mandible
  3. To compare the efficacy of eggshell derived hydroxyapatite (EHA) with commercially available synthetic hydroxyapatite (SHA)in terms of bone regeneration by densitometer after 3,6 and 9 months following periapical cyst enucleation in maxilla and mandible

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研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients with periapical cystic lesions (1.5-2 cm in diameter) of the maxilla and mandible involving up to three teeth, as confirmed by clinical and radiological evaluations, will be included in the study.
  • Patients in the age group of 18-40 years.
  • Patients who will give written informed consents.

排除标准

  • Immunocompromised individuals including those with severe debilitating diseases,
  • Pregnant and lactating female participants.
  • Individuals with endocrine disorders.
  • Patients in which satisfactory endodontic treatment cannot be done.

结局指标

主要结局

The effect of grafting will be evaluated using digital radiographic imaging technique and computer densitometry in bone regeneration at time intervals of 3,6 and 9 months following periapical cyst enucleation.

时间窗: The effect of grafting will be evaluated using digital radiographic imaging technique and computer densitometry in bone regeneration at time intervals of 3,6 and 9 months following periapical cyst enucleation.

次要结局

  • The effect of grafting will be evaluated using digital radiographic imaging technique and computer densitometry in bone regeneration at time intervals of 3,6 and 9 months following periapical cyst enucleation.(4,7,10 months)

研究者

发起方
Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DrNeha Agarwal

Dr.DY Patil dental college and hospital,Dr.DYPatil vidyapeeth,Pune

研究点 (1)

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